In an adequacy audit, the organization chart for Company A showed that the Quality Assurance Manager reports to the Production Manager.

Section A

The quality system documentation for company B showed no evidence or procedure for quality management system planning.

Section A

During a conformance audit, the auditees who are the inspectors in the incoming quality control section, were not aware of the company’s quality policy or objectives.

Section A

The Engineering Director was responsible for the conduct of review of requirements related to the product. There were no records of such reviews and the actions arising. The Engineering Director claimed that all contracts were signed with well-established clients and relationships were excellent.
He dismissed the need for a written record for contract review unless the auditor could prove that his current review was wrong. He claimed that he could clearly recall the important events in any review
which he had carried out.

Section A

Section B

Section B

In the stores of a company manufacturing pharmaceutical products, some cartons were unidentified, and their shelf life was not indicated. The store person insisted that he knew the products well and no problems would occur.

Section B

During a surveillance audit in a PCB (printed circuit board) fabrication company, the calibration laboratory showed excellent record keeping and control of their calibrated equipment. However, the Laboratory Supervisor was unable to produce records to verification of previous measuring results when the equipment is found to be out-of-calibration.

Section A

Section B

The work instructions for the assembly of a motherboard used in a desktop computer required all Operators to ground themselves using wrist-straps. One operator did not follow the instructions. She claimed that she is allergic to the straps and the Supervisor had agreed to exempt her. The Supervisor produced a medical certificate to back his concession towards the Operator.

Section A

Section B

A handwritten amendment was found on the incoming acceptance procedure which required a random sample size of 80 to be selected from the incoming lot. The acceptance number is 0 and rejection number is 1. The amendment which has no date or approval, comprised changing the
original sample size of 50 to 80. The incoming Quality Control Engineer claimed that he had exercised his initiative to correct the mistake. He produced the latest Mil Std 105E which showed that for sample code letter J, the sample size is n = 80, Ac= 0, Re = 1 for 0.65% acceptable quality level for the single normal inspection. He claimed that he had informed management of the “error” but had not received a reply. In any case, he claimed that the impact of his unapproved change was negligible.

Section A

Section B

The soldering section in a high-tech disk drive manufacturing company was unable to produce training records for three new operators. The operators for the critical soldering operations were required to pass a test before they were permitted to perform the operation. The Supervisor-in-charge claimed that for new operators the records were kept by training department, and he was still waiting for the copy of qualification and training records from the Training Department. He produced a set of inspection records from the Quality Assurance Department to show that the three new operators could produce good soldering work. In the meantime, he telephoned the Training Department to forward the training records. The records reached the auditor before he left the soldering section.

Section A

A training school offered certified training programs. Examination was conducted by the school with examination papers and other practical requirements examined by independent parties. Feedbacks from the participants were being kept. All feedbacks were excellent but there were occasional
feedbacks of favoritism. The school was unable to explain why there were no investigation or follow-up on the complaints.

Section A

Section B

The retention period for quality records was stipulated as three years for television sets assembled
by a company. It was found that some records were kept up to ten years while others up to only six months. The Management Representative explained that three years was the average period and that some records required longer period while others required shorter period. He was able to show a list which categorized the retention period for the records. He claimed that there was no need for such meticulous record keeping and it would be a waste of his time to keep records under bolts and nuts.

Section A

Section B

Section A

Section B

The management review procedure in a hotel requires a review every six-monthly interval and record to be maintained. The auditor found that no review was carried out during the last eight months. The Management Representative claimed that the peak tourist season had prevented them from carrying
out the review. He produced documentation showing excellent feedbacks from customers to show that service performance was unaffected by the omission of management review. In addition, he claimed that an informal review was carried out verbally during a lunch meeting two months ago.

Section A

Section B

During a certification audit, an outgoing inspection report on a batch of contaminated beverage containers showed that the entire batch was disposed. There was no other information on who approved the disposal and what corrective actions were taken. The supervisor claimed that it was normal to dispose contaminated beverage and he had used his initiative on several occasions. He claimed that only good products could pass through his stringent inspection and that for the last five years he had never received any complaint.

Section A

Section B

A subcontractor not listed in the approval vendors list was used to complete a welding job for the hull
of a ship. There was no documentation showing that a waiver was given. The Management
Representative claimed that for urgent work a verbal waiver was good enough. The foreman in-charge of the subcontracting work showed his diary indicating that he obtained verbal approval from the
Engineering Manager before engaging the subcontractor. The Engineering Manager claimed that he gave the waiver as the job was extremely urgent but admitted that he had no idea of the subcontractor’s work records. He explained that he had to trust his foreman’s recommendations on many occasions.

Section B

Inspectors in a printing company specializing in printing colorful brochures were not tested for color blindness. The Management Representative claimed that all their inspectors were doing good jobs and
such tests were not necessary.

Section A

During a surveillance visit to a precision machine tool manufacturer, the auditor found that the calibration laboratory supervisor had retired. The new supervisor was unable to produce the relevant documents requested by the auditor. However, the Management Representative was able to show that the calibration activities were being carried out according to documented procedures. He claimed that there was a skill labour shortage, and he was personally training the new supervisor. No non- conformance was found in the calibration laboratory with the exception that the supervisor was unable to carry out calibration according to the stipulated procedures. The Management Representative claimed that the supervisor would be professionally trained within three months.

Section A

Section B

Internal audits at a small construction company employing twenty employees were carried out by the foreman. Some auditees audit their own activities. A civil Engineer who was the Management
Representative for the company claimed that such practice was unavoidable given the size of his company.

Section A

Section B

Production plans which were used by a company manufacturing handphones to define product characteristics, use of equipment and manpower, delivery dates and arrangements. However, production plans for several current production were not documented. The supervisor claimed that there were too many plans and documentation for all these plans would be unrealistic.

Section A

Section B

Maintenance work instructions for all soldering machines were not documented. The supervisor explained that each machine had its own maintenance requirements specified by the maintenance manual. He claimed that it was too onerous to control these procedures.

Section A

Section B

Calibration stickers for two signal generators were missing. The supervisor in-charge, however, showed that the calibration was still valid by tracing the calibration records. He claimed that such missing stickers were unavoidable as there were many test instruments in his section.

Section A

Section B

In a pre-assessment audit, the training department in a bank has no procedures to identify the training needs for all personnel. The Training Department Manager explained that his bank had been operating for twenty years and the work had been routine. She claimed that there was no need for training needs identification and competency assessment.

Section A

Section B

An air-conditioning company gave a warranty of ten years for all compressors used in the air-conditioning system and provided for servicing of their installation at a nominal fee for the first two years. There was no work instruction for servicing. The Management Representative claimed that the two-year servicing for air-conditioning installation is part of the warranty, and the company had
no need for a work instruction.

Section A

Section B

Section A

Section B

During a certification audit, the design department of a company was unable to show how design activities were assigned to qualified personnel. The Engineering Manager claimed that their designers were all qualified but produced no evidence. She was unable to describe how the designers were qualified. The Design Manager claimed that based on their performance she qualified them but could not produce any document to back his claim. In addition, there was no review or definition of the organization and technical interfaces which inputs were necessary for the design process.

Section A

Section B

A copy of the ISO 9001:1994 was found in the training department. The department had carried out regular training in ISO documentation and audit for operators and supervisors.

Section A

Section B

During a certification audit, the design department was unable to produce evidence of performing design verification activities. In the design verification procedure approved by the company, design verification was supposed to include any of the following:

a) performing alternative calculations

b) comparing the new design with similar proven design, if available

c) undertaking tests and demonstrations

d) reviewing the design stage documents before release

The Design Manager explained that they were in the process of implementing the procedure and had asked for a grace period of three months.

Section A

Section B

During the certification audit, the auditor asked the hospital to test “blue code” which is used for emergency call. Many doctors and nurses rushed to the destination and started treatment. But they had to wait for the defibrillator for 30 minutes. In the relevant procedure, the responsible function for provision of that machine was not defined. However, they accepted that the sooner they got the machine, the more chance the patient could be survived.

Section A

The work instruction required the vaccine to be stored at 5–10degree C. According to the temperature monitoring record in pediatric clinic, the temperature was around 12–15degree C during noon time every day. The head of that clinic said that she had informed the maintenance department many times, but no action taken.

Section B

During the certification audit, the computer system of the hospital was down. The manager of computer department accepted that there was no back up system nor parallel system to run yet because this was the first time. She also accepted that this affected the effectiveness of the services and might affect the patient’s satisfaction because most of the operators were not used to working
manually. There was no procedure concerning about working under this situation neither.

Section A

Section B

The hospital provided home visit after the patient was discharged to satisfy the patient and to verify the effectiveness of the treatment. But the head of this section could not answer when asked what the actions are to be taken when the patient complained during such home visits.

Section A

Section B

In the emergency cart, the auditor found that there was no identification of antiseptics and chemicals. The head of the emergency unit explained that it was not necessary to do that because everybody knew these drugs very well and most of these were in different color.

Section A

Section B

The procedure required pharmacist to verify the drug before sending to the ward. The pharmacist allowed the pharmacist assistant to do the job instead. She said that she was too busy to do that. She also claimed that here assistant was very experienced in verifying drug and until today there still was no mistake.

Section A

Section B

In labor room, the auditor found that the packing of some equipment was torn especially the vacuum cup and delivery forceps. The head of labor room accepted that this minor torn packing would affect the sterility of the equipment. She claimed that she reported to the Central Supply Unit many times about this but there was no response.

Section A

In ABC Catering Company, once customer complaint was received as under:
“Our Contract says that the quality of rice to be used for rice-based dishes should be an “Australian Rice only” and you would be giving proof of calories should comply to specifications as per “Sheet “ABC_SPEC212 issue 2 Dt. 12th Jan 2022” and you would be giving us a 3rd party laboratory test report every quarter of the year and we have not received any evidence till now. Last month we performed a system audit and were surprised to note that the audit team raised the same issue in the form of Non-Conformance report (NC- 15; Dt.
21 Aug 2022) which is not yet closed. Please note the following:

We are taking a stand on this, as we need to submit 3 evidences to our customers and all of them are concerned on this issue; we cannot afford to lose our clients, as they are prestigious international airlines. This is very important for our business standards and
reputation. Hope you realize the criticality of the situation and comply to the requirements ASAP. On this ABC company responded in the following manner:
“We have been faxing all the evidence to the number as defined in the contract. Yes, we did not confirm whether you have received or not. We have all the evidence of the faxes sent to you in our files and were shown to your auditors when they were here to perform the 2nd party audits. Please confirm if the fax is working or has changed.
In future we shall be emailing the evidence to your Quality department. And also, we shall be uploading all these evidence in our internal intranet and provide you the password for access (only to authorized personnel -as identified by you), to avoid such issues occurring again.
The NCR-15 clearly mentions that one report is missing, which we agreed and responded to you (after rectifying our recording system) for closure and requested you to formally close the NCR which is pending from your end for acceptance of the actions and close out.
We assure you the best of services at all times to come. We thank you for this opportunity for improvement which we feel that without you pointing out, our communication system would not have improved.

While doing the audit of Sheet Metal Components for various industry sectors, you found that one of the gauges (GO- NOGO) for final inspection of circular product was found to be broken from one of the sides. On asking the inspector using the gauge, you were informed that it was supplied by the client & would be returned to the client with the last consignment. On verification of the Quality Manual, you also detected that this company where you are presently auditing, had sought exclusion for Customer Property.

Section A

Section B

A company manufacturing compasses for pleasure crafts. During the audit you observed that, to do the inspection of the centricity pin (the arrow in the compass which points to north), the person lifts a liver to lift the pin up & visually verified the parallel level or the pin with the surface. You as an auditor observed that the person doing the job is wearing thick glasses and hands shaking. On enquiry you came to know that the person is the senior most person in the company since last 20 years and very experienced in compasses – the only inspector in the company and his hands shakes because of some kind of illness. Through the complaints register you also establish that nearly 3% of the consignments on an average comes back from the market and are replaces by the company free of cost. It was further established by you that on re-verification of some of the samples from the stock ready to delivery, revealed that they also have problem of centricity.
Note: A pleasure craft (speed boat) moves very fast in water compared to big ships which, even turns very slowly. The precision and swiftness of the compass indications are the key quality norms acceptability.

Section A

Section B

While review of Management Review Meeting minutes, recorded the issue as – The brand retail business started operation in one county and due to local laws, they had to recruit local manpower, but their English was not good enough to sell the products to prospective customers mainly foreigners. This was identified during interview process also. Human Resources developed competency matrix and detailed job descriptions and translated to local language. These local personnel had no problems in selling products to local community but failed to sell products to foreign guests, due to problem in communication. As per the Law there is a restriction that female employees will not interact with males and vice versa. HR & Operational Management identified this problem but were not able to balance the Law and business requirements, for nearly a year due to which business targets were not able to meet business objectives (sales & branding). This aspect was taken up for discussion in Management Review and it was recorded in the minutes of meeting that local regulatory labor authorities would be contacted for solutions.

Section B

While auditing the Internal Audit Process, you noticed that one of the internal audits NC reveals the fact that internal audit frequency was annually and 70% of the 3 internal audit results revealed that the non-conformities were on Product Quality. You also noted that there were no changes in the Quality plan, inspection sampling plan & no trainings imparted in quality inspections.

Section B

The result of a student (with Slr. #: 098703) of a computer institute has appeared in the Final evaluation for ORACLE 8 (5 months diploma course). During the audit as a member of audit team towards ISO 9001:2015, you required to verify the records of this student. Following were the facts which were revealed from the records (soft & hard copy):

Section A

Section B

Using ISO 9001 to provide the audit criteria, you are auditing an organization that produces electronic components. You are discussing with the Quality Manager how the organization deals with the customer complaints. You
establish that they have detailed procedures in place that require them to investigate complaints and take appropriate action. You review the complaints they have received during the previous 12 months and note that several customers have recently made repeated complaints with respect to faulty components being delivered. The faulty components were returned to the organization by the customers. The organization repaired them and returned them to the customers. You ask to see the reports on the investigation for these complaints. The report show that the cause was the use of 02 new employees in the inspection department who were not fully trained to the requirements of the job profile at the time and who, due to staff shortages, were not supervised. The action shows that they were subsequently trained and assessed as being competent. The report also states that the investigations also examined the reasons why the components were manufactured with faults and corrective action was put in place to ensure the manufacturing problem could not be repeated. There have been no further customer complaints since these 02 issues have been addressed and the investigation and corrective action has been closed.

Section A

Section B

You are conducting an audit of the process for the Measurement Traceability. You see a box containing parts that are neatly stacked and accompanied by production paperwork in a plastic sleeve. You examine the paperwork, which appears to be complete and accurate and shows this to a repeat order. You see a comment “Customer supplied gauge # A123 to be used to verify components meet the requirements given in drawing XB 113 Rev 2”. The gauge is numbered A123 and appears to be in good condition although well used. You ask the inspector to show you the calibration records for the gauge. The inspector responds “We do not have any calibration record for it. We receive it from the customer with their order, the drawings and nothing else. We used it and the components are all acceptable according to the gauge.

Section A

Section B